Resources: Reference library, Glossary

Module Overview

Duration:
This module should take 60-120 minutes to complete

Certification:
A certificate is issued once a minimum of 80% is achieved in the final quiz section

Prerequisites:

1. ICH Good Clinical Practice

2. Introduction to Good Clinical Laboratory Practice

Summary:
'Organisation and Personnel' is the second module of the seven module course 'Good Clinical Laboratory Practice'. This module concentrates on the roles and responsibilities of laboratory personnel as defined by GCLP and analyses the structure, organisation and training of personnel involved in a clinical trial. Drawing on GCLP guidelines this module will outline the ways in which GCLP compliance can be achieved and maintained throughout the lifetime of the trial.

Objectives:
Upon successful completion of this course, you should be able to:

  • Outline the GCLP requirements for organisation within a clinical laboratory
  • Explain the different roles and responsibilities defined by GCP and GCLP
  • Describe how to organise a GCLP compliant laboratory
  • Understand the how GCLP responsibilities are implemented in the laboratory

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation, the World-Wide Antimalarial Resistance Network and The East African Consortium for Clinical Research.

Authors:

Carmelita Africa - Clinical Project Associate, International Partnership for Microbicides. Web

Liam Boggs - Training Manager, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford. Web

Paramesh Chetty - Senior Manager,Clinical Laboratory Programme - Africa, International AIDS Vaccine Initiative (IAVI). Web

Rhea Coler - MSc, PhD, VP, Preclinical Biology, Infectious Disease Research Institute (IDRI). Web

Helen Demarest - Associate Director, Clinical Operations, Medicines for Malaria Venture (MMV). Web

Sebastian Gelderbloem - Managing Director, Aeras Africa. Web

Lakshmi Jayashankar - Senior Scientific Officer, Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD. Web

Wendy Keller - Quality Assurance Manager, DNDi - Drugs for Neglected Diseases initiative. Web

Nnamdi Nwachukwu - PATH Vaccine Solutions. Web

Mahnaz Vahedi - Special Programme for Research and Training in Tropical Diseases. Web

Reviewers:

Hannelie Carstens, PhD - Director Quality Management and Compliance, International Partnership for Microbicides

Maureen Lambrick - Sr. Manager Lab Development Services, Tuberculosis, Aeras Africa

Motiur Rahman, MBBS, PhD - Head of Laboratories, Centre for Tropical Medicine, Oxford University Clinical Research Unit, HO CHi Minh City, Vietnam

Use and reproduction of these e-learning materials:
These e-learning materials are owned by the Global Health Network. You are free to share or adapt this material but you must attribute it to the Global Health Network using the link www.theglobalhealthnetwork.org

Resources: Reference library, Glossary

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